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EMD Millipore, the life science division of Merck KGaA, and PharmaCell B.V. today announced a collaboration to develop optimized large-scale expansion and harvest of HepaRG® cells using bioreactor technology. The companies will work together to produce protocols and methods for efficient expansion, harvest and use of HepaRG® cells in support of the BALANCE project, which is funded by the Seventh Framework Programme of the European Committee and aims to create bioartificial livers.

Large-scale methods to produce cells have typically been manufactured in multi-layer flasks. Bioreactors provide a method that can meet the needs of large-scale production for safe and effective delivery of cell-based therapies. Ultimately the project is expected to deliver scalable expansion and harvesting devices, validation methods and associated protocols for the production of large-scale stem cell therapies.

Large-scale "industrialized" production of cells is necessary to enable their advancement into human clinical trials and to effectively deliver the quantities efficiently and effectively. However, achieving this level of production while meeting rigorous quality standards will depend on further progress in the areas of cell culture and scale-up, characterization, enrichment and purification to deliver a consistent and reproducible supply of cells.

"As more cell-based therapeutics progress towards clinical testing, the consistency, quality and reproducibility of large-scale culture systems become an imperative," notes Robert Shaw, Commercial Director of EMD Millipore's Stem Cell Initiative. "The ability to ensure that a population of cells can be reproducibly produced in a manner that can be validated is critical to the success of clinical applications. The technologies developed as part of this collaboration will help enable this and move the field forward."

"We are excited to work with EMD Millipore to develop the future technologies for large-scale industrial production of human cells. EMD Millipore's world-class technical expertise in bioreactors combined with PharmaCell's advanced know-how in culturing human cells positions the team well to create solutions to overcome some significant technical hurdles in the field and lower future cost of goods sold for our clients," expresses Alexander Vos, Chief Executive Officer, PharmaCell BV.

This collaboration is another step in the development of a platform of scalable, disposable production solutions to help enable manufacturers of cell-based therapies.

PharmaCell provides GMP contract manufacturing services and process development solutions in the area of cell therapy and regenerative medicine. They will be utilizing the Mobius® bioreactor platform in support of this project.